Posted 24 March 2017
By Zachary Brennan
Medical device companies and other stakeholders have until 30 April to apply to be a part of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP), which is meant to help agency staffers better understand medical devices.
The training program, which is not intended for FDA to inspect, assess, judge, or perform a regulatory function (e.g., compliance inspection), is "is intended to provide CDRH staff with an opportunity to understand the policies, laboratory and manufacturing practices, and the challenges addressing patient perspective/input, quality system management, and other challenges that impact the device development life cycle," FDA said.
Current training needs include: Biocompatibility, combination products, clinical trials, digital health/software, import shipping facilities, in vitro diagnostics, manufacturing, postmarket assessment, quality management, reprocessing and sterilization, standards conformity assessment testing and innovation.
CDRH says it encourages participation from companies, academia, and clinical facilities, medical device incubators and accelerators, health insurers, health technology assessment groups and others, including those that have previously participated in the ELP or other FDA site visit programs.
CDRH's Experiential Learning Program